Approval · Notice of Compliance 573 · 2002
GEMZAR: Notice of Compliance 573
Issued January 21, 2002
A Notice of Compliance is Health Canada’s approval of a drug submission: a new drug, a new use or form, or a change to an approved one. The product itself is in the Drug Product Database, with its current status.
- Notice number
- 573
- Date
- January 21, 2002
- Company
- Eli Lilly Canada IncToronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Priority
- Reason
- New indication: for the use in combination with cisplatin for patients with stage iv (locally advanced or metastatic) transitional cell carcinoma (tcc) of the bladder
- Therapeutic class
- Antineoplastic
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| GEMZAR | Not yet assigned | — |
Medicinal ingredients
- GEMCITABINE HYDROCHLORIDE 200 MG per VIAL
- GEMCITABINE HYDROCHLORIDE 1 G per VIAL